Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Zolpidem Tartrate Tablets containing Zolpidem Tartrate 10 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Ambien® Tablets 10 mg containing Zolpidem Tartrate 10 mg (Reference , Sanofi-Synthelabo Inc) in Healthy Human Volunteers Under Fed Condition.

Inclusion criteria

• The subjects who qualify for the study should meet the following inclusion criteria.

• Male and female subjects in the range of 18 - 45 years of age.
• Subjects having Body Mass Index (BMI) in a range of 18.5 to 24.9.
• Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and body temperature)
• Subjects with normal findings as determined by hematological tests, serum chemistry, urine analysis, ECG and X-ray.
• Willingness to follow the protocol requirement as evidenced by written, informed consent.
• Agreeing to, not using any medication prescription and over the counter medicines including vitamins and minerals for 14 days prior to study and during the course of the study.
• No history or presence of significant alcoholism or drug abuse in the past one year.
• Non-smokers, ex smokers and light smokers will be included. " Light smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers as someone who completely stopped smoking for at least 3 months.

Exclusion criteria

• The subjects who qualify for the study should not meet the following exclusion criteria:

• Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day1.
• Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
• History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic diseases.
• Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
• History of malignancy or other serious diseases.
• Refusal to abstain from food for at least ten (10) hours prior to High Fat Breakfast and for additional four (4) hours post dose during each study period.
• Refusal to abstain from water for at least one (1) hour prior to study drug administration on each study period and for at least two (2) additional hours, post dosing.
• Any contraindication to blood sampling.
• Use of xanthine-containing beverages or food and grapefruit juice for 48 hours prior to each drug dose.
• Blood donation 90 days prior to the commencement of the study.
• Subjects with positive HIV tests, HbsAg or Hepatitis-C tests.
• Known history of hypersensitivity to zolpidem Tartrate or to any of the inactive ingredients in the formulation.
• Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period.
• Pregnant and lactating women.
• Use of prescription medication within 14 days prior to administration of study medication or over the counter products (including natural food supplements,vitamins, garlic as a supplement) within 14 days prior to administration of study medication, except for topical products without systemic absorption.
• Female subjects whose menstruation cycle coincides with the study periods.